, June 14, 2012
/PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP) today announced additional development progress of its next generation rPA anthrax vaccine, SparVax, which is being developed to provide protection against anthrax exposure during a national security emergency. Following on the successful cGMP manufacturing of SparVax at full commercial scale, the Company has now completed final analytical testing and release of the final drug product in pre-filled syringes for future clinical evaluation.
Dr. Thomas Fuerst, Executive Vice President and Chief Scientific Officer commented, "This latest achievement represents another major step forward for our SparVax program. We now know that SparVax manufactured in the United States meets all of the specifications and potency metrics necessary to begin clinical studies. SparVax has previously been evaluated in two separate Phase II clinical trials involving approximately 770 subjects. This latest Phase II trial, which we expect will commence in the second half of this year, will be a dose-ranging and schedule study designed to evaluate the safety and immunogenicity of SparVax in approximately 300 healthy subjects."
A key differentiator for PharmAthene's rPA technology platform is the utilization of E. coli. This technology enables a more robust manufacturing process and the capability of annually producing more than 150 million rPA vaccine equivalent doses of bulk drug substance (at a 50 mcg dose) a substantial improvement in rPA production yield compared to the first generation anthrax vaccine.
PharmAthene's rPA anthrax vaccine program has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Disease, National Institutes of Health and the Biomedical Advanced Research and Development Authority.
About PharmAthene, Inc.
PharmAthene was formed to meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons. PharmAthene's lead product development programs include:
- SparVax - a second generation recombinant protective antigen (rPA) anthrax vaccine
- Valortim® - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
- rBChE - a novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents
In addition, pursuant to an opinion issued September 22, 2011 from the Delaware Court of Chancery, PharmAthene is entitled to 50% of the profits over 10 years from all sales of SIGA Technologies' ST-246 - a novel smallpox antiviral agent being developed by SIGA for the treatment and prevention of morbidity and mortality associated with exposure to the causative agent of smallpox (once SIGA earns $40 million in net profits from sales of ST-246).
For more information about PharmAthene, please visit www.PharmAthene.com.
Statement on Cautionary Factors
Except for the historical information presented herein, matters discussed may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; "should"; "will"; "project"; "potential"; or similar statements are forward-looking statements. PharmAthene disclaims any intent or obligation to update these forward-looking statements other than as required by law. Risks and uncertainties include risk associated with the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates, unexpected funding delays and/or reductions or elimination of U.S. government funding for one or more of the Company's development programs, the award of government contracts to our competitors, unforeseen safety issues, challenges related to the development, scale-up, technology transfer, and/or process validation of manufacturing processes for our product candidates, unexpected determinations that these product candidates prove not to be effective and/or capable of being marketed as products, challenges related to the implementation of our NYSE Amex compliance plan, as well as risks detailed from time to time in PharmAthene's Forms 10-K and 10-Q under the caption "Risk Factors" and in its other reports filed with the U.S. Securities and Exchange Commission (the "SEC"). In particular, at this point there can be no assurance that PharmAthene's rPA product candidate will be shown to be safe and effective and approved by regulatory authorities for use in humans. Copies of PharmAthene's public disclosure filings are available from its investor relations department and our website under the investor relations tab at www.PharmAthene.com.
SOURCE PharmAthene, Inc.